By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
DrugPatentWatch Database Preview
VISTOGARD Drug Profile
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When do Vistogard patents expire, and what generic alternatives are available?
Vistogard is a drug marketed by Wellstat Therap and is included in one NDA. There are two patents protecting this drug.
This drug has one hundred and seventy-five patent family members in twenty-one countries.
The generic ingredient in VISTOGARD is uridine triacetate. There are thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.
DrugPatentWatch® Generic Entry Outlook for Vistogard
Vistogard was eligible for patent challenges on September 4, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 10, 2023. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VISTOGARD
| International Patents: | 175 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Patent Applications: | 191 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in VISTOGARD? | VISTOGARD excipients list |
| DailyMed Link: | VISTOGARD at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for VISTOGARD
Generic Entry Date for VISTOGARD*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GRANULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for VISTOGARD
| Ingredient-type | Pyrimidines Analogs/Derivatives |
| Drug Class | Pyrimidine Analog |
US Patents and Regulatory Information for VISTOGARD
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for VISTOGARD
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | Try Before You Buy | Try Before You Buy |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VISTOGARD
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 920007395 | Try Before You Buy |
| Austria | 93236 | Try Before You Buy |
| Australia | 2722688 | Try Before You Buy |
| Denmark | 176007 | Try Before You Buy |
| Japan | H02500373 | Try Before You Buy |
| Japan | 4067926 | Try Before You Buy |
| Australia | 7881398 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VISTOGARD
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1849470 | 2017/033 | Ireland | Try Before You Buy | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425 |
| 1849470 | LUC00036 | Luxembourg | Try Before You Buy | PRODUCT NAME: TRIFLURIDINE COMBINEE AU TIPIRACIL OU UN SEL DE TIPIRACIL TEL QUE L'HYDROCHLORURE DE TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427 |
| 1849470 | 2017C/028 | Belgium | Try Before You Buy | PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427 |
| 1849470 | 17C1028 | France | Try Before You Buy | PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427 |
| 1849470 | CA 2017 00036 | Denmark | Try Before You Buy | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427 |
| 1849470 | 300889 | Netherlands | Try Before You Buy | PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427 |
| 1849470 | 1790063-0 | Sweden | Try Before You Buy | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
